EUCTR2012-002271-34-DE
Active, not recruiting
Not Applicable
A phase III, randomized, double-blind, parallel group study to evaluatethe efficacy and safety of linagliptin 5 mg compared to placebo,administered as oral fixed dose combination with empagliflozin 10 mgor 25 mg for 24 weeks, in patients with type 2 diabetes mellitus andinsufficient glycaemic control after 16 weeks of treatment withempagliflozin 10 mg or 25 mg on metformin background therapy.
ConditionsDiabetes mellitus type 2 is the medical condition to be investiagtedMedDRA version: 16.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes mellitus type 2 is the medical condition to be investiagted
- Sponsor
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Enrollment
- 690
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Diagnosis of type 2 diabetes mellitus prior to informed consent
- •2\. Male and female patients who have received diet and exercise counselling and who are pre\-treated with an unchanged dose of immediate release metformin for at least 12 weeks prior to Visit 2\.
- •Minimum dose for metformin is defined as:
- •\=1500 mg/day of metformin or
- •maximum tolerated dose (the investigator must have documented the reason why uptitration to e.g. \= 1500 mg/day was not possible) or
- •maximum dose according to the local label (the investigator must have documented the local label requirements in the medical records)
- •3\. HbA1c \= 8\.0% (64 mmol/mol) and \= 10\.5% (91 mmol/mol) at Visit 1 for randomization into the 16 week treatment period.
- •4\. HbA1c \= 7\.0% (53 mmol/mol) and \= 10\.5 % (91 mmol/mol) at Visit 4 for randomization into the 24 week treatment period.
- •5\. Age \= 18 years
- •6\. Body Mass Index (BMI) \=45 kg/m2 at Visit 1 (screening) as calculated in the eCRF.
Exclusion Criteria
- •1\. Uncontrolled hyperglycaemia with a glucose level \>270 mg/dl (\>15\.0 mmol/L) after an overnight fast during the open label period (from Visit 2 to Visit 4\) and placebo add on run\-in period (Visit 4 to Visit 5\) confirmed by a second measurement (not on the same day and done either at the central or local laboratory).
- •2\. Any other antidiabetic drug within 12 weeks prior to Visit 2 randomization (except metformin background therapy as defined via inclusion criterion 2\).
- •3\. Acute coronary syndrome (non\-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent
- •4\. Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) based on Visit 1 or Visit 4 laboratory parameters.
- •Note: Each value should be assessed independently of one another, i.e Visit 1 assessments will determine randomization to the open label treatment period and Visit 4 assessments will determine randomization to the double blind treatment period
- •5\. Impaired renal function, defined as eGFR \<60 ml/min/1\.73 m2 (MDRD formula) as determined during screening (Visit 1\) or placebo add on run\-in (Visit 4\)
- •Note: Each eGFR value should be assessed independently of one another, i.e Visit 1 assessments will determine randomization to the open label treatment period and Visit 4 randomization and assessments will determine randomization to the double blind treatment period
- •6\. Known hereditary galactose intolerance
- •7\. Known contraindications to metformin or linagliptin according to the local label (where marketed)
- •8\. Any previous (within the past two years) or planned bariatric surgery (or any other weight loss surgery) or other gastrointestinal surgery that induces chronic malabsorption
Outcomes
Primary Outcomes
Not specified
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